BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERTAPE CERCLAGE SUTURE

    MDR report key: 11581750 · Received March 29, 2021

    Report

    Report Number
    1220246-2021-02787
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    March 10, 2021
    Report Date
    March 29, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    JDQ
    UDI-DI
    00888867274129
    PMA / PMN Number
    K170206
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DISTAL FEMUR FRACTURE SURGERY THREE FIBERTAPES (AR-7267, LOT S705864) BROKE INSIDE THE PATIENT WHILE USING THE CERCLAGE TENSIONER (AR-7800, LOT 051650). ONE BROKE DURING INITIAL TENSIONING AND THE SECOND AND THIRD BROKE WHEN THE FINAL TENSIONING ON TOP OF THE HALF HITCH WAS DONE. ALL THREE DEVICES BROKE IN THE KNOT. THE BROKEN DEVICE CERCLAGE WAS REMOVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. THE SURGEON SWITCHED TO A CERCLAGE WIRE IN METAL. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483947 FIBERTAPE CERCLAGE SUTURE CERCLAGE, FIXATION JDQ ARTHREX, INC. FIBERTAPE CERCLAGE SUTURE S705864 00888867274129

    Patients

    Seq Age Sex Outcome Treatment
    1